Details
The U.S. Food and Drug Administration (FDA) initiated this study in the Sentinel System to support the Office of Surveillance and Epidemiology’s active safety monitoring plan for therapeutics granted Emergency Use Authorization (EUA) status for the treatment of coronavirus disease 2019 (COVID-19). EUA authority allows FDA to strengthen the nation’s public health protections by authorizing unapproved medical products or unapproved uses of approved medical products during public health emergencies, such as the COVID-19 pandemic. The COVID-19 EUA safety monitoring plan aims to provide a mechanism for capturing serious adverse events (known, suspected, or previously unknown) during the EUA period. The goal of the monitoring plan is signal identification and characterization.
FDA launched a series of analyses over the COVID-19 pandemic to periodically assess whether the use of several therapeutics for COVID-19 treatment under EUA followed the authorized use of these products, as well as describe patient outcomes, including anaphylaxis and hospitalization rates, after receiving outpatient COVID-19 treatments under EUA. Additionally, FDA sought to estimate the magnitude of the “at-risk” population who used drugs that interact with Paxlovid (nirmatrelvir and ritonavir) to inform product labeling.
In total, FDA assessed the following COVID-19 EUA therapeutics: bamlanivimab, bamlanivimab/etesevimab, baricitinib, bebtelovimab, casirivimab/imdevimab, molnupiravir, nirmatrelvir and ritonavir, remdesivir, and sotrovimab. The periodic EUA monitoring analysis suggested that the COVID-19 EUA treatment use followed the Fact Sheet directives and did not identify new safety signals. The drug interaction assessment indicated that more than 50% of Paxlovid-eligible patients may have been on drugs that could interact with Paxlovid. However, most of the commonly used drugs that are involved in these drug-drug interactions with Paxlovid do not seem to prevent patients from taking Paxlovid, as they can be temporary withheld or adjusted to lower dose. Prescribers should be aware of the risk of drug interaction and refer to the Paxlovid label and other appropriate resources for comprehensive information on the drug interaction risk management.
Findings from the drug interaction assessment were included in the FDA’s New Drug Application review of Paxlovid, which emphasizes adverse reactions as a key component of the safety review. After reviewing the totality of the information available, FDA added a boxed warning to the Paxlovid label to underscore the drug interaction risk.